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Outcomes at One Year With the Gore Excluder Iliac Branch Endoprosthesis
Sharif Ellozy1, Darren Schneider, MD1, Jon Mastumura, MD2.
1Weill Cornell Medicine, New York, NY, USA, 2University of Wisconsin, Madison, WI, USA.

Objectives
The Gore Excluder Iliac Branch Endoprosthesis (IBE; W.L. Gore, Flagstaff, AZ) is an iliac branch stent graft designed to preserve perfusion to both the internal and external iliac arteries during endovascular repair of aortoiliac aneurysms (AIAs) and common iliac artery aneurysms (CIAAs). We will report 30 day and 12 month outcomes for the IBE device from two data sources: the IBE 12-04 US pivotal trial and the Global Registry for Endovascular Aortic Treatment (GREAT), a commercial product registry.
Methods
All data included in this report are from subjects that underwent placement of an IBE. The United States (US) pivotal trial prospectively enrolled 64 patients and 63 patients underwent implantation of the IBE at 28 centers from 2013 to 2015. There are 58 subjects with the IBE implanted in GREAT from 14 centers that were prospectively enrolled in Europe from 2013 to 2016.
Results
Data from the US pivotal trial revealed overall technical success (successful deployment, patency of all IBE components and freedom from type 1 or 3 endoleak) was 95.2% and there was no procedural mortality. Data from 61 patients were available for primary and secondary effectiveness endpoint analysis. Internal iliac limb patency was 95.1% and there were no new type 1 or 3 endoleak or device migrations observed at 6-months. The 3 patients with loss of internal iliac limb patency were asymptomatic. Freedom from new onset buttock claudication on the IBE side was 100% at 6-months. Procedural data from GREAT reveals similar results with only 1 endoleak (type Ib), no mortality and no serious events for device occlusions or buttock claudications reported. GREAT 6 month data revealed additional reports of 1 type Ib endoleak and 1 thrombosis of the iliac artery. Both data sets will have updated 1 year data available at the time of presentation.
Conclusions
These results confirm that the IBE is safe and effective at treating AIAs and CIAAs, maintaining blood flow into the internal iliac artery, and preventing complications associated with internal iliac artery sacrifice.


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